MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-18 for TOTAL BILIRUBIN 06L45-41 manufactured by Abbott Manufacturing Inc.
[142481084]
(b)(6). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[142481085]
While using the clinical chemistry total bilirubin assay, the customer indicated that decreased bilirubin results were generated after calibration was completed with a new lot of calibrator. The customer provided the following data for an adult patient (provided reference range 3 - 21 umol/l): note: the retest results were generated after calibration was completed with new lot of calibrator. The customer indicated the initial results were considered correct. Sid (b)(6), initial 10. 7, after retest 7. 0, sid (b)(6), initial 5. 4, retest 3. 0, sid (b)(6), initial 9. 3, retest 4. 9, sid (b)(6), initial 7. 0, retest 3. 3, sid (b)(6), initial 7. 1, retest 4. 1, sid (b)(6), initial 10. 6, retest 5. 3, sid (b)(6), initial 13. 2, retest 9. 3, sid (b)(6), initial 17. 9 , retest 11. 4, sid (b)(6), initial 26. 6 , retest 20. 4, sid (b)(6), initial 21. 1, retest 13. 2. There has been no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00318 |
| MDR Report Key | 8527450 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-18 |
| Date of Report | 2019-06-05 |
| Date Mfgr Received | 2019-06-05 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2019-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL BILIRUBIN |
| Generic Name | TOTAL BILIRUBIN REAGENT |
| Product Code | CIG |
| Date Received | 2019-04-18 |
| Catalog Number | 06L45-41 |
| Lot Number | 54494UQ01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-18 |